How is a trial designed and run?
How trials are planned
Researchers draw up a protocol
Questions about health care which lead to trials can come from patients, people working in the NHS, researchers, organisations that fund research, drug companies or policymakers.
Researchers planning a trial will draw up a protocol. This is the detailed plan for the trial, and it must include:
- What the trial is aiming to find out
- The design of the trial – for example how many different groups there will be, whether the trial will be blinded
- How many people will be recruited
- The eligibility criteria – who can take part in the trial
- What treatments are being compared
- What tests people taking part in the trial will have and when they should have them
- Details about how and when information will be collected
When researchers apply for funding to run a trial, the protocol is sent for independent scientific review. If the trial is funded, the researchers send the protocol to an ethics committee for approval. The trial cannot start without ethics committee approval.
Who pays for trials?
Many different organisations might pay for trials to take place. For example:
- NHS or Medical Research Council - At the MRC Clinical Trials Unit, we run trials funded by the MRC and the NHS (via the National Institute of Health Research)
- Government agencies who might want to help address health problems in developing countries. At the MRC Clinical Trials Unit we are running trials funded by the Department for International Development and by the USA’s USAID
- Charities who want to find out more about best treatments for a particular illness, such as Cancer Research UK.
- Drug companies conduct most clinical trials in the UK and elsewhere. They need to run trials to test new drugs or other treatments. At the MRC Clinical Trials Unit, drug companies help to fund some of our trials and may also give us the drugs we are testing free of charge or at a reduced price
Monitoring the progress of trials
Trials must be monitored as they go along, to ensure that everything is going as planned
Many phase III trials need to involve thousands of people, and they may run for a long time – sometimes five years or longer. Trials must be monitored as they go along, to ensure that everything is going as planned. A [trial management group] (CTUWebsite/glossary) is responsible for running the trial on a day-to-day basis. At the MRC Clinical Trials Unit many trial management groups include patient representatives. There is usually an independent data monitoring committee, which monitors the progress of a trial.
There is also usually a trial steering committee, which makes sure the trial is running well. This committee might include patient representatives as well as the researchers leading the trial, doctors and nurses and an independent chairperson.
[diagram of how a clinical trial is run?]